Workflow role
Diagnostic ultrasound acquisition, visualization, fluid-flow analysis, and professional review support.
exact submission · checked 2026-09-04This is a submission-anchored intended-use summary, not a local acceptance result.
FDA-cleared profile
Butterfly Gestational Age Tool
Butterfly Network, Inc.
Authorized purpose: Butterfly Gestational Age Tool estimates gestational age for a singleton intrauterine pregnancy presumed to be 16 to 37 weeks within the labeled Butterfly ultrasound workflow; qualified professionals must review the output.
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.
Product overview
Start with the essentials
Authorized purpose: Butterfly Gestational Age Tool estimates gestational age for a singleton intrauterine pregnancy presumed to be 16 to 37 weeks within the labeled Butterfly ultrasound workflow; qualified professionals must review the output.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Butterfly Gestational Age Tool estimates gestational age for a singleton intrauterine pregnancy presumed to be 16 to 37 weeks within the labeled Butterfly ultrasound workflow; qualified professionals must review the output.
- Which images or clinical context are in scope? Modality: Ultrasound Anatomy or clinical context: Obstetric/Fetal Input: Ultrasound acquisitions from supported probes, modes, presets, patient populations, and release-specific configurations.
- Who uses it? Intended users: Qualified and trained ultrasound professionals.
- What does the software produce? Output: Ultrasound image series, flow data, measurements, and release-specific derived outputs for professional review.
- What is its most important limitation? Key limitation: Probe, mode, anatomy, patient population, acoustic window, workflow, and optional-feature limits vary by exact system and release. Butterfly Gestational Age Tool estimates gestational age for a singleton intrauterine pregnancy presumed to be 16 to 37 weeks within the labeled Butterfly ultrasound workflow; qualified professionals must review the output.
Clinical takeaway
Clinical role: Butterfly Gestational Age Tool estimates gestational age for a singleton intrauterine pregnancy presumed to be 16 to 37 weeks within the labeled Butterfly ultrasound workflow; qualified professionals must review the output.
Evidence takeaway
Evidence from the reviewed source record: The exact FDA submission K252148 is the identity anchor. Its public decision material supports the submission-specific product and intended-use summary recorded here; it does not establish a general product-wide sensitivity or specificity value for this dossier.
Clinical details
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
- Exact purpose
- Butterfly Gestational Age Tool estimates gestational age for a singleton intrauterine pregnancy presumed to be 16 to 37 weeks within the labeled Butterfly ultrasound workflow; qualified professionals must review the output.
- Intended users
- Qualified and trained ultrasound professionals.
- Care setting and population
- Hospital, clinic, point-of-care, and procedural settings covered by the exact ultrasound labeling.
- Workflow role
- Diagnostic ultrasound acquisition, visualization, fluid-flow analysis, and professional review support.
- Required input
- Ultrasound acquisitions from supported probes, modes, presets, patient populations, and release-specific configurations.
- Output and human action
- Ultrasound image series, flow data, measurements, and release-specific derived outputs for professional review.
- Limitations
- Probe, mode, anatomy, patient population, acoustic window, workflow, and optional-feature limits vary by exact system and release. Butterfly Gestational Age Tool estimates gestational age for a singleton intrauterine pregnancy presumed to be 16 to 37 weeks within the labeled Butterfly ultrasound workflow; qualified professionals must review the output.
Regulatory identity
FDA record and catalog context
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Implementation
Questions for IT, informatics, and operations
Use these fields to structure a vendor demo, security review, and implementation estimate.
- Integration
- Not established in reviewed sources
Exact submission evidence and the current vendor family material do not establish the exact site's DICOM, worklist, PACS/RIS, identity, routing, display, or fallback behavior.
- Deployment and data flow
- Not established in reviewed sources
Exact deployment topology, hosting, network boundaries, update mechanism, and local operational requirements are not established for this submission.
- Security and privacy
- Not established in reviewed sources
Public sources reviewed here do not establish the complete exact-release security posture, including identity, audit, encryption, retention, remote access, vulnerability management, backup, or incident response.
- Training and support
- Vendor documentation pending
Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
- Monitoring and change control
- Vendor documentation pending
Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
Input
Ultrasound acquisitions from supported probes, modes, presets, patient populations, and release-specific configurations.
exact submission · checked 2026-09-04Exact supported inputs and protocol limits must be confirmed from the complete labeling.
Output
Ultrasound image series, flow data, measurements, and release-specific derived outputs for professional review.
exact submission · checked 2026-09-04Output review, editing, and downstream use remain release- and site-specific.
Vendor family context
Current vendor material is product-family context for K252148 only; exact release, enabled options, deployment, and local interoperability require confirmation.
product family · checked 2026-09-04Vendor material is not exact-release evidence unless that linkage is separately proven.
Site validation status
Exact local interfaces, deployment topology, security controls, downtime behavior, and support obligations remain unestablished.
exact submission · checked 2026-09-04Obtain organization-specific implementation evidence before procurement or clinical use.
Evidence
Performance evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.
- Evidence summary
- The exact FDA submission K252148 is the identity anchor. Its public decision material supports the submission-specific product and intended-use summary recorded here; it does not establish a general product-wide sensitivity or specificity value for this dossier.
- Reported sensitivity
- Not established in reviewed sources
No exact submission and version-linked sensitivity endpoint is published in this dossier; do not substitute a product-family or candidate-study value.
- Reported specificity
- Not established in reviewed sources
No exact submission and version-linked specificity endpoint is published in this dossier; do not substitute a product-family or candidate-study value.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
FDA submission-specific verification and validation evidence for K252148
- DesignRegulatory verification, validation, and labeling evidence reviewed for exact FDA submission K252148.
- PopulationThe labeled population and test materials for exact submission K252148; a general clinical study population is not established here.
- Scopeexact submission
- Tested versionButterfly Gestational Age Tool (K252148)
- IndependenceSponsor or vendor study
K252148
FDA regulatory evidence is submission-specific but is not independent clinical performance evidence.
Costs and setup
Budget and ongoing governance
These are common procurement questions; unknown values remain visible until a source supports them.
- Pricing and total cost
- Not established in reviewed sources
No public exact-release price, license fee, subscription, contract, or implementation cost was established in this review.
- Reimbursement and coding
- Not applicable
CMS index context was checked, but no product-specific coverage or reimbursement determination is inferred.
Safety and lifecycle
Postmarket record
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
- Postmarket safety review
- Not established in reviewed sources
No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
Buyer worksheet
Open questions to take to the vendor
- Verify DICOM, HL7/FHIR, PACS/RIS/EHR integration: Exact submission evidence and the current vendor family material do not establish the exact site's DICOM, worklist, PACS/RIS, identity, routing, display, or fallback behavior.
- Verify deployment and data flow: Exact deployment topology, hosting, network boundaries, update mechanism, and local operational requirements are not established for this submission.
- Verify security and privacy controls: Public sources reviewed here do not establish the complete exact-release security posture, including identity, audit, encryption, retention, remote access, vulnerability management, backup, or incident response.
- Verify training: Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
- Verify pricing and total cost: No public exact-release price, license fee, subscription, contract, or implementation cost was established in this review.
- Verify reimbursement and coding relevance: CMS index context was checked, but no product-specific coverage or reimbursement determination is inferred.
- Verify local validation and lifecycle monitoring: Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
- Verify recalls and postmarket safety signals: No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
Research record
What has been checked
This audit distinguishes completed source review from fields that have not yet been researched.
Exact FDA record reviewedStatus
2026-09-19Last searched
28Fields reviewed
13Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external evidence was promoted. The current discovery snapshot contains 0 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.
Source classes: fda ai list, fda decision summary, vendor product page, implementation documentation, reimbursement policy, peer reviewed literature, clinical trial registry, fda device recall, literature index, trial registry, pubmed, clinical trials, openfda device recall
Sources & history
How this profile was documented
Open the ledger for source dates, scope, and research-record updates.
View source ledger and history
Source ledger
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FDA decision summary for K252148 - Butterfly Gestational Age Tool
Scope: regulatoryIdentity, productIdentity, indication, modality, anatomy, workflowRole, input, output, limitations, evidenceSummary
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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PubMed biomedical literature index
Scope: evidenceDiscovery
-
ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
Medicare Coverage Database
Scope: coverage, codingContext
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
Butterfly ultrasound family context
Scope: productFamilyContext, workflowRole, implementationCapabilities
Research history
-
K252148 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
fda record reviewed
-
Reader overview source-reviewed
Editorial review
Source-reviewed editorial overlay
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